Desmopresina stada 120 microgramos comprimidos sublinguales efg

Patient Information Leaflet: Desmopresina Stada 120 microgramos sublingual tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1. What is Desmopresina Stada and what is it used for

2. What you need to know before you start taking Desmopresina Stada

3. How to take Desmopresina Stada

4. Possible side effects

5. Storage of Desmopresina Stada

6. Contents of the pack and additional information

The active ingredient, desmopresin, ofDesmopresina Stada, is a natural vasopressin hormone analog that regulates the kidneys' ability to concentrate urine.

Desmopresin is used for the treatment of :

• Central diabetes insipidus (a pituitary disorder that leads to intense thirst and the production of a large amount of pale, watery urine).
• Nocturnal enuresis in children aged 5 years and above with normal ability to concentrate urine (involuntary nighttime urination during sleep).
• Nocturia in adults under 65 years (a condition in which a person wakes up frequently at night to urinate).

Do not take Desmopresina Stada:

• if you are allergic to desmopresin or any of the other ingredients of this medicine (listed in section 6)
• if you have polydipsia (abnormally high intake of liquids), heart failure, and other conditions that require treatment with diuretics
• if you have a moderately or severely reduced renal function
• if you have low sodium levels in your blood
• if you cannot respect the fluid restriction
• if you have an altered hormonal secretion (SIADH)
• if you are over 65 years old and have nocturia (see section 1)
• if your child is under 5 years old and has nocturnal enuresis (see section 1)

Warnings and precautions

The control of nocturnal enuresis (involuntary nocturnal urination) in children begins with lifestyle measures and an alarm for nocturnal enuresis (a device that produces a sound or vibrates when wet). If these measures fail or pharmacological therapy is needed, treatment with desmopresin can be initiated.

Consult your doctor before starting to take this medicine

• if you have coronary artery disease (blood vessels that irrigate the heart) or high blood pressure
• if you have a thyroid disease (gland in the throat) or adrenal gland disease (gland above the kidney)
• if during treatment you have an illness that causes fever, vomiting, diarrhea
• if during your treatment you feel headache, loss of appetite, nausea, vomiting, weight gain, confusion (difficulty understanding words, attention difficulties) or convulsions (violent and involuntary contractions of one or more limbs); these symptoms may be signs of a dangerous condition known as hyponatremia (low sodium levels in the blood)
• • for the treatment of central diabetes insipidus: you must reduce your water intake and consult a doctor immediately. Your doctor will reduce the doses or interrupt the treatment for several hours.
  • for the treatment of nocturnal enuresis or nocturia: you must suspend the treatment, reduce your water intake, and consult a doctor immediately.
• if you have a risk of increased intracranial pressure

When treating nocturnal enuresis and nocturia, fluid intake should be limited to the minimum possible to control thirst during the period from 1 hour before to 8 hours after taking this medicine.

Desmopresin should be used with caution in patients with fluid balance disorders. Talk to your doctor if, in relation to an acute illness, you have a fluid-electrolyte imbalance.

Children

In children, the use of this medicine should be carried out under the supervision of an adult.

Do not administer this medicine to children under 5 years old.

Other medicines and Desmopresina Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including over-the-counter medicines.

The effect of this medicine may increase, with a greater risk of abnormal fluid retention, if taken at the same time as certain medicines used to treat:

• depression (such as tricyclic antidepressants, selective serotonin reuptake inhibitors)
• psychosis (such as chlorpromazine)
• epilepsy (such as carbamazepine)
• diabetes (so-called sulfonylureas, for example, chlorpropamide)
• diarrhea (such as loperamide)
• pain and inflammation (so-called NSAIDs)

The effect of this medicine may be reduced if taken at the same time as certain medicines for:

• gas in the stomach (such as dimethicone)

Use of Desmopresina Stada with beverages

If you are taking this medicine for nocturnal enuresis or nocturia, you should limit your fluid intake from 1 hour before taking the tablet to 8 hours after taking it.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The experience of use during pregnancy is limited.

Desmopresin passes into breast milk, but it is unlikely to affect infants.

Driving and operating machines

Desmopresin has no or insignificant effect on the ability to drive and operate machines.

Desmopresina Stada contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per sublingual tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dosage is set by your doctor, who will adjust it individually for you.

This medication should be taken always at the same time.

The sublingual tablet should be placed under the tongue where it dissolves without water.

Diabetes Insipidus:

The usual dosage for adults and children is 1 to 2 sublingual tablets (60 micrograms) 3 times a day.

Enuresis:

The usual dosage is 1-2 sublingual tablets (120 micrograms) under the tongue at night. Take this medication at bedtime. Fluid intake should be limited.

Your doctor will monitor you every three months to see if treatment should be continued. Your doctor may establish a period without treatment of at least one week.

Nocturia in Adults

The usual dosage is 1 sublingual tablet (60 micrograms) under the tongue before bedtime.

Fluid intake should be limited.

Use in Children

This medication is used to treat diabetes insipidus and nocturnal enuresis (see above for dosages for different treatment conditions). The dosage is the same for children and adults only for diabetes insipidus.

If You Take More Desmopressin Stada Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone (91) 562 04 20 indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If you take more medication than you should or if, for example, a child has accidentally ingested the medication, contact a doctor, hospital, or pharmacist immediately for risk assessment and advice.

Taking too much desmopressin can prolong the effect of this medication and increase the risk of fluid retention in the body and low sodium levels in the blood. Severe fluid retention symptoms include seizures and loss of consciousness.

If You Forget to Take Desmopressin Stada

Do not take double doses to compensate for missed tablets.

If you have any other doubts about the use of this product, consult your doctor or pharmacist.

If You Stop Taking Desmopressin Stada

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If liquid intake is not limited according to the previous instructions, abnormal amounts of fluid can accumulate in your body, which can cause headaches, stomach pain, nausea/vomiting, weight gain, dizziness, confusion, general discomfort, feeling of spinning, and in severe cases, seizures and coma.

These signs may reflect a water retention that is more or less important. They usually appear with high doses of this medicine and disappear when the dose is reduced.

Adults

Very common(may affect more than 1 in 10 people):

• Headache

Common(may affect up to 1 in 10 people):

• Low sodium levels in the blood
• Dizziness
• Hypertension
• Stomach pain
• Nausea
• Diarrhea
• Constipation
• Vomiting
• Urinary and urethral discomfort
• Swelling of hands, arms, feet, or legs
• Fatigue

Uncommon(may affect up to 1 in 100 people)

• Difficulty sleeping
• Somnolence
• Tickling
• Visual disturbances
• General feeling of spinning (dizziness)
• Feeling of heartbeats
• Low blood pressure when standing up from a lying position
• Difficulty breathing
• Indigestion, flatulence, or bloating
• Sweating
• Itching
• Rash
• Urticaria
• Muscle spasms
• Muscle pain
• Chest pain
• Symptoms similar to the flu
• Weight gain
• Increased liver enzymes
• Low potassium levels in the blood.

Rare(may affect up to 1 in 1,000 people)

• Confusion
• Allergic skin inflammation.

Frequency not known(the frequency cannot be estimated from the available data)

• Anaphylactic reaction (severe allergic reaction)
• Dehydration
• High sodium levels in the blood
• Seizures
• Weakness
• Coma.

Children

Common(may affect up to 1 in 10 people)

• Headache.

Uncommon(may affect up to 1 in 100 people)

• Emotional changes.
• Aggression
• Nausea
• Stomach pain
• Vomiting
• Diarrhea
• Urinary and urethral discomfort
• Swollen hands and feet
• Fatigue.

Rare(may affect up to 1 in 1,000 people)

• Anxiety
• Nightmares
• Mood changes
• Somnolence
• Hypertension
• Irritability.

Frequency not known(the frequency cannot be estimated from the available data)

• Anaphylactic reaction (severe allergic reaction)
• Low sodium levels in the blood
• Abnormal behavior
• Emotional disturbances
• Depression
• Hallucinations
• Difficulty sleeping
• Reduced attention
• Increased muscle movements.
• Cramp
• Nasal bleeding
• Rash
• Allergic skin inflammation.
• Sweating
• Urticaria.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in the original packaging to protect it from moisture.

This medication does not require any special storage temperature.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDesmopresina Stada

-The active ingredient is desmopressin

Each sublingual tablet contains 120 micrograms of desmopressin (as acetate).

-The other components are: lactose monohydrate, cornstarch, citric acid, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the packaging

Desmopresina Stada are white or almost white, octagonal, biconvex tablets engraved with 'II' on one face and smooth on the other, approximately 6.5 mm in length/width.

Desmopresina Stada is supplied in a cardboard box containing standard blisters or pre-cut single-dose blisters with integrated aluminum/aluminum desiccant layer, with 10 tablets each, in packaging of 10, 30, and 100 sublingual tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Haupt Pharma M?nster GmbH

Schleebrüggenkamp 15,

D-48159 Münster,

Germany

or

Adalvo Ltd.

Malta Life Sciences Park,

Building 1, Level 4,Sir Temi Zammit Buildings,

San Gwann, SGN 3000

Malta

or

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Last review date of this leaflet:June2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/